Protocol summary
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Study aim
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1.Determination of the effect of intravenous fluid therapy on amniotic fluid index in oligohematerialis.
2.Comparison of the mean of amniotic fluid index before and after intravenous fluid therapy in mothers with oligohydramnios.
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Design
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Firstly, women of the age group of 35 or more gestational age who are willing to participate in the research with a written consent and who have the characteristics of the research unit are selected and embedded in the experimental group.
Each mother in the study will receive 3000 ml of Ringer serum within 24 hours. 48 hours after administration of intravenous fluid therapy, sonography is performed to determine the amniotic fluid index for mother.
The present study does not have control group.
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Settings and conduct
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Firstly, oligohydramnios women with a gestational age of 35 weeks or more who were referred to Iran Hospital of Iranshahr are selected and embedded in the experimental group.In the experimental group, the study will receive 3000 milligrams of Ringer serum within 24 hours. For 48 hours after administration of intravenous fluid therapy, sonography is performed to determine the amniotic fluid index for both groups. Blinding was performed for data analyzers. .
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Participants/Inclusion and exclusion criteria
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Inclusion Criteria:
Single pregnancy; Intact Amniotic Sac; gestational age greater than or equal to 35 weeks; amniotic fluid index less than or equal to 5 cm.
EXclusion Criteria:
Normal Amniotic Fluid index; Polyhydramnios.
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Intervention groups
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In the intervention group, each mother will receive 3000 ml of Ringer serum within 24 hours. After 48 hours of intravenous fluid administration, sonography is performed to determine the amniotic fluid index.
The present study does not have control group.
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Main outcome variables
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Amniotic fluid index.
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20160418027464N3
Registration date:
2019-05-14, 1398/02/24
Registration timing:
prospective
Last update:
2019-09-22, 1398/06/31
Update count:
1
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Registration date
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2019-05-14, 1398/02/24
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-05-18, 1398/02/28
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Expected recruitment end date
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2019-08-23, 1398/06/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of intravenous fluid therapy on amniotic fluid index in oligohydramnios.
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Public title
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Effect of Intravenous hydrotherapy on "Ammonium fluid reduction"
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Purpose
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Basic scienece
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Inclusion/Exclusion criteria
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Inclusion criteria:
Single pregnancy
Intact Amniotic fluid
Gestational age greater than or equal to 35 weeks
َAmniotic fluid index less than or equal to 5 cm.
Exclusion criteria:
Normality of the amniotic fluid index.
Polyhydramnios
Twin Pregnancy
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Age
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No age limit
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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N/A
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Single
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Other design features
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The study design was a quasi-experimental clinical trial without control group.
Ethics committees
1
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Ethics committee
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Approval date
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2015-10-25, 1394/08/03
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Ethics committee reference number
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IR.IRSHUMS.REC.1394.11
Health conditions studied
1
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Description of health condition studied
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Oligohydramnios
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ICD-10 code
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O41.9
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ICD-10 code description
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Disorder of amniotic fluid and membranes, unspecified
Primary outcomes
1
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Description
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Amniotic fluid index.
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Timepoint
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48 hours after intervention.
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Method of measurement
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Sonoghraphy
Secondary outcomes
1
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Description
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Amniotic Fluid Index.
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Timepoint
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48 hours after intervention.
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Method of measurement
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sonography.
2
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Description
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Apgar the first minute
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Timepoint
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Immediately after childbirth
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Method of measurement
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Newborn Clinical Examination
Intervention groups
1
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Description
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Intervention group: In the experimental group, the study will receive 3000 cc of Ringer serum within 24 hours and will be performed in the routine care control group for oligohematerial patients. 48 hours after administration of intravenous fluid therapy, sonography was performed to determine the amniotic fluid index for the group. It will be
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Iranshahr University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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It is not necessary.
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available